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FDA to require species-specific antimicrobial data

​Posted June 15, 2016

Pharmaceutical companies will need to give federal authorities data that could be used to compare antimicrobial consumption and resistance by livestock species.

The Food and Drug Administration already requires that drugmakers provide annual data on sales of antimicrobials approved for use in livestock species. The rule finalized in May, which takes effect in July, will require that future reports include estimates on what percentage of each drug is consumed by each livestock species. Each annual report is due by the end of March the following year.

A federal register notice published May 11 states that the additional data will help the FDA examine how sales trends relate to antimicrobial resistance, as will data the agency plans to collect on how the drugs are administered on farms. The new sales data also will help agency officials assess progress toward reducing injudicious use.

That goal entails reducing the frequency of administering antimicrobials in feed or water when those drugs are in classes shared with human medicine. FDA guidance published in December 2013 gave pharmaceutical companies three years to agree to changes in drug approvals to eliminate over-the-counter access to such drugs and production uses of them, such as administration for growth promotion.

Under such agreements, access to antimicrobials that are in classes used in human medicine will require a prescription or a veterinary feed directive. All affected pharmaceutical companies have agreed to those drug approval changes, which the FDA plans to make by December.